Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• Mesoblast (MESO), 1,575% surge in interest
• Aslan Pharmaceuticals (ASLN), 1,229% surge in interest
• Aprea Therapeutics (APRE), 562% surge in interest
• Lexicon Pharmaceuticals (LXRX), 126% surge in interest
• Moderna (MRNA), 88% surge in interest

Pipeline and key clinical candidates for these companies:

Mesoblast refers to itself as “a world leader in developing allogeneic cellular medicines for the treatment of severe and life-threatening inflammatory conditions.” The company states: “Mesoblast has a strong and extensive global intellectual property portfolio with protection extending through to at least 2041 in all major markets… Rexlemestrocel-L is in development for advanced chronic heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the company has established commercial partnerships in Europe and China for certain Phase 3 assets.”

Aslan Pharmaceuticals is a clinical-stage, immunology-focused biopharmaceutical company developing eblasakimab, a potential first-in-class antibody targeting the IL-13 receptor in moderate-to-severe atopic dermatitis with the potential to improve upon current biologics used to treat allergic disease, and has reported positive topline data from a Phase 2b, dose-ranging study in moderate-to-severe AD patients. Aslan is also developing farudodstat, a potent oral inhibitor of the enzyme dihydroorotate dehydrogenase, as a potential first-in-class treatment for alopecia areata in a Phase 2a, proof-of-concept trial with an interim readout expected in mid-2024.

Aprea Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality. The company’s lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor in development for solid tumor indications. Aprea has completed all IND enabling studies for its oral, small molecule WEE1 inhibitor, APR-1051, and recently received FDA clearance of its IND.

Lexicon says it is “pioneering the discovery and development of innovative medicines to safely and effectively treat disease.” Lexicon has advanced one of these medicines to market and has a “pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, diabetes and metabolism and other indications,” the company states.

Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA, or mRNA, to “an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale,” the company states. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has “allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.” Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of vaccines against the COVID pandemic. The company is pursuing the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.

Recent news on these stocks:

March 12

Lexicon Pharmaceuticals announced that a post hoc analysis of clinical data from its inTandem3 Phase 3 trial demonstrated that treatment with sotagliflozin resulted in improved glycemic control in patients with type 1 diabetes and chronic kidney disease. In this important patient population, treatment with sotagliflozin successfully lowered A1C, body weight, and systolic blood pressure with safety similar to the total study cohort. The efficacy and safety data were presented last week at ATTD 2024 – 17th International Conference on Advanced Technologies and Treatments for Diabetes in Florence, Italy. Using data from the 24-week, multinational, placebo-controlled trial, the effects of sotagliflozin 400 mg daily added to insulin therapy on A1C, body weight, systolic blood pressure, eGFR, total insulin dose, adjudicated severe hypoglycemia and DKA were evaluated in a subgroup of patients with type 1 diabetes and CKD. Relative to placebo, treatment with sotagliflozin led to similar reductions in A1C, body weight and systolic blood pressure in the CKD and total cohorts. Sotagliflozin was associated with similar risks of severe hypoglycemia between the two cohorts.

RBC Capital told investors in a research note that following the start of a third potentially pivotal trial in resectable squamous cell carcinoma, two additional Phase II trials have been posted on ClinicalTrials.gov and that Moderna and Merck (MRK) will explore their cancer vaccine as an add-on to pembrolizumab in the adjuvant settings for bladder cancer and renal cell carcinoma. RBC likes that both trials are randomized, that both companies have the confidence to start randomized Phase II trials in tumor types where there is yet to be data and that both indications are large opportunities. The firm likes that Phase III is now up and running and remains a believer in the cancer vaccine approach. RBC has an Outperform rating and $125 price target on Moderna shares.

March 11

Aslan Pharmaceuticals has begun to enroll patients in the U.S. under an updated protocol in the ongoing TREK-DX trial, studying eblasakimab in dupilumab-experienced patients with moderate-to-severe atopic dermatitis. TREK-DX is the first randomized, double-blind, placebo-controlled trial to be conducted in AD patients who have been previously treated with dupilumab, a market estimated to reach $10B by 2029. Based on findings from the TREK-AD study which highlighted the changing AD patient population in the US, the TREK-DX inclusion criteria have been tightened to enroll patients with a baseline Eczema Area and Severity Index score of at least 18, instead of 16. In conjunction with this, independent reviewer confirmation of baseline EASI scores has also been implemented. U.S. sites are now enrolling patients according to the updated criteria and additional sites in Europe are on track to open in the first half of 2024. TREK-DX will enroll approximately 75 patients who have discontinued dupilumab treatment for any reason, including inadequate control of AD, loss of access or an adverse event, and treat them with either 400mg eblasakimab or placebo once weekly for 16 weeks. At the time of the data cut off for this preliminary review of blinded data from 22 patients enrolled under the original inclusion criteria, who were randomized 2:1 active to placebo, 17 patients completed the 16 week treatment period and 5 patients discontinued before the completion of the 16 week treatment period. At 16 weeks or the last visit, EASI score decreased at least 90% in 10 patients, or 45%, and 11 patients, or 50%, achieved a validated Investigator Global Assessment score of 0 or 1. Of the 9 patients who previously had an inadequate response to dupilumab, 5 patients achieved EASI-90 and 5 patients a vIGA score of 0 or 1. Treatments have been well-tolerated to date and no new safety signals were identified. There have been no reports of conjunctivitis and no reports of injection site reactions. Topline unblinded data from the full dataset is expected at the end of 2024. Translational data demonstrates differentiated effects of targeting IL-13R versus IL-4R, suggesting eblasakimab has the potential to be effective even in instances where dupilumab is not: Eblasakimab targets the IL-13 receptor subunit of the Type 2 receptor, preventing signaling through both interleukin 4 and interleukin 13. Both are key drivers of inflammation in AD, however, recently published translational data highlighted the advantages of targeting IL-13R by eblasakimab over the IL-4 receptor, the target of dupilumab, in AD patient peripheral blood mononuclear cells4. IL-13R blockade resulted in more efficient reduction of cytokines implicated in Type 2-driven inflammation compared to IL-4R blockade, as well as lower levels of Type 1 pro-inflammatory cytokines. Additional data from head-to-head studies between eblasakimab and dupilumab in skin biopsies from AD patients confirmed the differentiated effects of targeting IL-13R versus IL-4R5. In this study, eblasakimab reduced localized secretion of pro-inflammatory Type 2 cytokines by the skin tissue more efficiently than dupilumab, suggesting eblasakimab could have the potential to be effective in AD patients that do not achieve an adequate response to dupilumab.

Piper Sandler said the firm is “confident” that a partner or potential acquirer will see the value and differentiation of monthly eblasakimab versus every other week Dupixent, including in the growing patient population of Dupixent inadequate responders, and expects a partner or potential acquirer will likely develop eblasakimab in other allergic indications beyond atopic dermatitis, or AD, such as COPD. The firm reiterated an Overweight rating and $15 price target on Aslan Pharmaceuticals after the company announced that it has begun to enroll patients in the U.S. under an updated protocol in the ongoing TREK-DX trial, studying eblasakimab in dupilumab-experienced patients with moderate-to-severe AD.

Aprea Therapeutics announced that the FDA has cleared its Investigational New Drug application for APR-1051. Clearance of the IND application will allow Aprea to initiate the Phase 1 ACESOT-1051 dose escalation trial to evaluate the safety, tolerability, and preliminary efficacy of APR-1051. Enrollment of the first patient in this study is expected in the first half of 2024 with an update expected in the fourth quarter of the year.

March 10

Mesoblast announced that the FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell product, in patients with end-stage ischemic heart failure with reduced ejection fraction and a left ventricular assist device. The FDA provided this feedback in formal minutes to the company following the Type B meeting held with FDA on February 21 for rexlemestrocel-L under the existing Regenerative Medicine Advanced Therapy designation. “We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu. “We intend to request a pre-Biologics License Application meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”

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About “Biotech Alert”

The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.

This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.

This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.